For products that are in development, we offer you a custom proposal to meet FDA Premarket requirements in a timely fashion. Our efficient approach positions your product for a successful launch.
At your Service
Focus 42 will partner with your organization during any phase of the product life-cycle. We provide the full service for all FDA Regulatory Requirements to support your timely product launch.
Regulatory Strategy
Market research, intended use, device classification, and full strategy for FDA submissions.
Quality System
Create Quality Process, Documentation, and SOPs. Provide comprehensive quality and regulatory training.
Audit Remediation
Internal, pre-certification, and mock FDA audits with gap analysis. Manage external audits.
FDA Premarket Approval
Prepare applicable FDA submission packages. Liaison with FDA to secure product approval.
Product Launch
FDA registration, device listing, official correspondence, and U.S. Agent service. Product Labeling review and compliance (UDI).
Postmarket Support
Monitoring of all FDA required records, files, and submissions. Continuous improvement process.
Free Custom RA Proposal
It is ultra-convenient to evaluate whether we can fulfill your Regulatory Affairs Partner needs. Based on where you are in the life-cycle for your device, we will create a proposal for you. Your customized proposal is ready to download and evaluate in minutes, and there is no obligation.
-
Launch
For products that are Exempt from, or already received FDA Clearance -or- Approval, we offer you a custom proposal for meeting the additional FDA requirements before your product can begin shipping into U.S. markets.
-
Postmarket
For products that meet FDA Premarket requirements for the U.S., we offer you a custom proposal for long-term sustaining services. This supports both you and your customers to meet FDA Postmarket requirements.